Precision Medicine: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) for Early-Stage Glottic Laryngeal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorViktoras Rudzianskas
About this trial
This randomized phase III trial will compare the outcomes of three treatment modalities for early-stage glottic laryngeal cancer (T1-T2N0): transoral CO₂ laser microsurgery (TLM), volumetric modulated arc therapy (VMAT), and MRI-guided stereotactic ablative radiotherapy (MRI-SABR). The primary endpoint is local control (LC). Secondary endpoints include laryngectomy-free survival (LFS), progression-free survival (PFS). overall survival (OS), functional voice, swallowing and breathing outcomes, treatment-related complications, and the evaluation of radiomic and dosiomic biomarkers. Patients will be randomized in a 1:1:1 ratio. Total planned enrollment is 105.
Eligibility criteria
Qualifiers
Age ≥18 years.
Histologically confirmed squamous cell carcinoma of the glottic larynx, including verrucous carcinoma.
Stage T1-T2N0 (8th TNM edition).
ECOG performance status 0-2.
Disqualifiers
AJCC stage III-IV laryngeal cancer.
Prior radiotherapy for head and neck cancer.
Pregnancy or breastfeeding.
Contraindications for radiotherapy or inability to follow-up.
Trial design
Treatments tested in this trial
- Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization)
- VMAT radiotherapy
- MRI-SABR
Treatment groups
105 Participants
are divided into 3 treatment groupsSponsors and collaborators
Viktoras Rudzianskas
Lead sponsor
Lithuanian University of Health Sciences
Sponsor institution
Source ClinicalTrials.gov